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Clinical Outcomes of Transplanted Modified Bone Marrow–Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study
Gary K. Steinberg, MD, PhD, Douglas Kondziolka, MD, Lawrence R. Wechsler, MD, L. Dade Lunsford, MD, Maria L. Coburn, BA, Julia B. Billigen, RN, BS, Anthony S. Kim, MD, MAS, Jeremiah N. Johnson, MD, Damien Bates, MD, PhD, Bill King, MS, Casey Case, PhD, Michael McGrogan, PhD, Ernest W. Yankee, PhD and Neil E. Schwartz, MD, PhD
3 mai 2016 - [Lien / stroke.ahajournals.org]
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AVC : L'espoir des cellules-souches
Juin 2016
Une étude réalisée par l'Université de Glasgow a montré que l'injection de cellules-souches dans le cerveau pouvait sensiblement améliorer l'état de patients ayant été victimes d'un accident vasculaire cérébral. Les premiers résultats montrent que cette injection de cellules-souches a permis des améliorations sensibles de l'état des patients, sans entraîner des effets secondaires notables. Des améliorations surprenantes ont été observées sur des malades qui étaient lourdement handicapés depuis plusieurs années. Nous avons notamment été surpris de voir que certains patients parvenaient à nouveau à marcher seuls et à reconnaître leur environnement et ces améliorations sensibles semblent persister dans le temps. .
A suivre...

Background and Purpose
Preclinical data suggest that cell-based therapies have the potential to improve stroke outcomes.

Methods
Eighteen patients with stable, chronic stroke were enrolled in a 2-year, open-label, single-arm study to evaluate the safety and clinical outcomes of surgical transplantation of modified bone marrow–derived mesenchymal stem cells (SB623).

Results
All patients in the safety population (N=18) experienced at least 1 treatment-emergent adverse event. Six patients experienced 6 serious treatment-emergent adverse events; 2 were probably or definitely related to surgical procedure; none were related to cell treatment. All serious treatment-emergent adverse events resolved without sequelae. There were no dose-limiting toxicities or deaths. Sixteen patients completed 12 months of follow-up at the time of this analysis. Significant improvement from baseline (mean) was reported for: (1) European Stroke Scale: mean increase 6.88 (95% confidence interval, 3.5–10.3; P<0.001), (2) National Institutes of Health Stroke Scale: mean decrease 2.00 (95% confidence interval, -2.7 to -1.3; P<0.001), (3) Fugl-Meyer total score: mean increase 19.20 (95% confidence interval, 11.4–27.0; P<0.001), and (4) Fugl-Meyer motor function total score: mean increase 11.40 (95% confidence interval, 4.6–18.2; P<0.001). No changes were observed in modified Rankin Scale. The area of magnetic resonance T2 fluid-attenuated inversion recovery signal change in the ipsilateral cortex 1 week after implantation significantly correlated with clinical improvement at 12 months (P<0.001 for European Stroke Scale).

Conclusions
In this interim report, SB623 cells were safe and associated with improvement in clinical outcome end points at 12 months.

Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT01287936.
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